Status:
RECRUITING
A Prospective, Observational, Single Centre Study to Assess the Feasibility of the Data Harvested by the Acorai Intracardiac Pressure Monitoring (ICPM) System in Predicting Prognosis in Patients Discharged From Hospital After Treatment for Acute Decompensated Heart Failure
Lead Sponsor:
Royal Brompton & Harefield NHS Foundation Trust
Conditions:
Heart Failure
Decompensated Heart Failure
Eligibility:
All Genders
18+ years
Brief Summary
Acorai is developing the Acorai Heart Monitor, a handheld electronic device for monitoring pressures inside the heart in a non-invasive manner, by placing the device on the chest of a patient. Current...
Detailed Description
There is a need for the development of a tool that can help to identify those HF patients at risk of deterioration. The ideal tool would be quick, easy to use, non-invasive, inexpensive and can be per...
Eligibility Criteria
Inclusion
- Subjects must meet all the following criteria to be eligible for participation in the clinical investigation
- Subjects medically fit for discharge following an admission to Hospital with decompensated heart failure requiring intravenous diuretic therapy
- Subject is willing and physically able to comply with the specified evaluations as per clinical investigation plan, as assessed by the investigator.
- Subject is able to provide written consent to participate in the study
Exclusion
- Pregnancy
- Discretionary exclusion when, in the opinion of the investigator, the inclusion of a potential subject is not in their best interest or not in the interest of compliant performance of the clinical trial
Key Trial Info
Start Date :
April 29 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06397833
Start Date
April 29 2024
End Date
February 1 2027
Last Update
April 8 2025
Active Locations (1)
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1
Harefield Hospital
Uxbridge, Middlesex, United Kingdom, UB9 6JH